Transplantation In Spain Research Articles

Costs Analysis of Kidney Transplantation in Spain: Differences Between Regional Health Services

Background: For our society, chronic kidney disease is a major public health problem associated with high mortality, morbidity, reduced quality of life and a progressive increase in health costs. The aim of this study was to analyze and compare the current cost of kidney transplantation (KT) and kidney–pancreas transplantation (KPT) among the different Regional Health Services (RHS) in Spain. Methods: A descriptive comparative study analyzing the public prices of RHS in Spain. The Official Gazette of the different communities was consulted, where the latest available order on this type of cost was sought. A descriptive analysis was made of the stipulated cost of the KT and KPT, for each degree of severity, RHS, year of publication and cost calculation method. Mean cost and standard deviation were calculated. Results: KT prices were found for 15 of the 18 RHS (83.33%). The average cost of KT in Spain was €33,926.53 ± 6950.053 (range from €23,140.37 in the Canary Islands to €48,205.75 in Catalonia). For KPT, costs were found for 5 of the 18 RHS (27.8%). The mean cost of KPT was €65,792.38 ± 11,273.12 (ranging from €49,418.81 in Navarra to €78,363.20 in Andalusia). Conclusions: There is a large variability in KT and KPT costs in Spain between RHS. Our study underlines the importance of adopting standardized and updated costing methods for KT and KPT.

First consensus document of waiting list prioritization for liver transplantation by the Spanish Society of Liver Transplantation (SETH).

Spain is worldwide leader in deceased donation rates per million habitants and count on a strong network of twenty-five liver transplant institutions. Although the access to liver transplantation is higher than in other countries, approximately 10% of patients qualifying for liver transplantation in Spain will die in the waiting list or would be excluded due to clinical deterioration. A robust waiting list prioritization system is paramount to grant the sickest patients with the first positions in the waiting list for an earlier access to transplant. In addition, the allocation policy may not create or perpetuate inequities, particularly in a public and universal healthcare system. Hitherto, Spain lacks a unique national allocation system for elective liver transplantation. Most institutions establish their own rules for liver allocation and only two autonomous regions, namely Andalucía and Cataluña, share part of their waiting list within their territory to provide regional priority to patients requiring more urgent transplantation. This heterogeneity is further aggravated by the recently described sex-based disparities for accessing liver transplantation in Spain, and by the expansion of liver transplant indications, mainly for oncological indications, in absence of clear guidance on the optimal prioritization policy. The present document contains the recommendations from the first consensus of waiting list prioritization for liver transplantation issued by the Spanish Society of Liver Transplantation (SETH). The document was supported by all liver transplant institutions in Spain and by the Organización Nacional de Trasplantes (ONT). Its implementation will allow to homogenize practices and to improve equity and outcomes among patients with end-stage liver disease.

Real-World Experience with Isavuconazole in Allogeneic Stem Cell Transplantation in Spain

Invasive fungal infections (IFI) pose a significant complication after hematopoietic stem cell transplantation (HSCT). Isavuconazole (ISV) is a new generation azole with a favourable adverse effect and interaction profile approved for the treatment of invasive aspergillosis and mucormycosis. We analyzed the indications, effectiveness, adverse event profile and drug interaction management of ISV in the real-world setting in adults who received allogeneic-HSCT (allo-HSCT) within the Spanish Group of HSCT and Cell Therapy (GETH-TC). We conducted a multicenter retrospective study of all consecutive adult allo-HSCT recipients (≥18 years) who received ISV either for IFI treatment or prophylaxis, from December 2017 to August 2021, in 20 centers within the Spanish Group of Hematopoietic Stem Cell Transplantation and Cell Therapy (GETH-TC). A total of 166 adult allografted patients who received ISV from 2017 to 2021 were included. Median age was 48 years with 43% females. In 81 (49%) patients, ISV was used for treatment of IFI, and in 85 (51%) for prophylaxis. Median duration of ISV administration for IFI treatment was 57 days (range 31-126) and 86 days (range 33-196) for prophylaxis. Most frequent indication for treatment was invasive aspergillosis (78%), followed by mucormycosis (6%). Therapeutic success (45%) was the most frequent reason for ISV withdrawal. In the prophylaxis group, the resolution of IFI risk factors was the most frequent reason for withdrawal (62%). Six (7%) breakthrough IFI were reported. The majority of patients (80%) presented pharmacologic interactions. Twenty-one patients (13%) reported adverse events related to ISV, mainly liver biochemistry abnormalities, which led to ISV withdrawal in 7 patients (4%). ISV was effective and well tolerated for IFI treatment and prophylaxis, with a manageable interaction profile.

Temporal trends and outcomes of heart transplantation in Spain (2002–2021): propensity score matching analysis to compare patients with and without type 2 diabetes

BackgroundThe impact of Type 2 Diabetes (T2D) on the outcomes of heart transplantation (HT) has not yet been clearly established. The objectives of this study were to examine the trends in the prevalence of T2D among individuals who underwent a HT in Spain from 2002 to 2021, and to compare the clinical characteristics and hospitalization outcomes between HT recipients with and without T2D.MethodsWe used the national hospital discharge database to select HT recipients aged 35 and older. The International Classification of Diseases, Ninth and Tenth Revisions (ICD-9 and ICD-10) were used to identify patients with and without T2D. We also recorded comorbidities, complications of HT, and procedures. Propensity score matching (PSM) and Cox regression were used to analyze the effect of T2D on in-hospital mortality (IHM).ResultsBetween 2002 and 2021, a total of 4429 HTs (T2D, 19.14%) were performed in Spain. The number of HTs in patients with T2D decreased from 2002 to 2005 (n = 171) to 2014–2017 (n = 154), then rose during 2018–2021 (n = 186). Complications of HT increased in patients with and without T2D over the study period (26.9% and 31.31% in 2002–2005 vs. 42.47% and 45.01% in 2018–2021, respectively). The results of the PSM showed that pneumonia and Gram-negative bacterial infections were less frequent in patients with T2D and that these patients less frequently required hemodialysis, extracorporeal membrane oxygenation (ECMO), and tracheostomy. They also had a shorter hospital stay and lower IHM than patients without diabetes. The variables associated with IHM in patients with T2D were hemodialysis and ECMO. IHM decreased over time in people with and without T2D. The Cox regression analysis showed that T2D was associated with lower IHM (HR 0.77; 95% CI 0.63–0.98).ConclusionsThe number of HTs increased in the period 2018–2021 compared with 2002–2005 in patients with and without T2D. Over time, complications of HT increased in both groups studied, whereas IHM decreased. The presence of T2D is associated with lower IHM.

Pediatric heart transplantation in spain after circulatory determination of death and in situ normothermic regional perfusion - ERRATUM.

Pediatric heart transplantation in spain after circulatory determination of death and in situ normothermic regional perfusion - ERRATUM.

An Interpretive Approach to Religious Ambiguities around Medical Innovations: The Spanish Catholic Church on Organ Donation and Transplantation (1954-2014).

How do institutionalized religions solve moral ambiguities around controversial medical innovations and public health issues? Most religions have moral guidelines about what can and cannot be done to people's bodies, but these guidelines are not always straightforward and, when faced with certain scientific advances, can come into contradiction with other doctrinal principles. I address this theoretical puzzle through the empirical case of the Spanish Catholic Church's discourse on organ donation and transplantation during the second half of the twentieth century. Drawing on an interpretive analysis of official statements by the Spanish Catholic Church, and of the media coverage of the religious debate over organ donation and transplantation in Spain from 1954 onwards, I show that the first experiments in organ transplantation faced the Church with a contradiction between its altruistic teachings and its beliefs in the sacredness of human life. Faced with an interpretive dilemma, the Church produced a context-specific version of its official doctrine friendly to organ donation and transplantation. It did so by activating its altruistic elements and suppressing sacralized meanings of the body, thus aligning organ donation with Catholic values of generosity and fraternal love. My study theorizes this moral alignment as a semantic overlap realized through historically situated institutional discourse. Additionally, it incorporates 24 primary and secondary sources on comparative cases to propose three facilitating factors that enabled and encouraged the Spanish Catholic Church to embrace a controversial medical practice.

Temporal trends in the use and outcomes of temporary mechanical circulatory support as a bridge to cardiac transplantation in Spain. Final report of the ASIS-TC study

We aimed to describe recent trends in the use and outcomes of temporary mechanical circulatory support (MCS) as a bridge to heart transplantation (HTx) in Spain. Retrospective case-by-case analysis of 1,036 patients listed for emergency HTx while on temporary MCS in 16 Spanish institutions from January 1st, 2010 to December 31st, 2020. Patients were classified in 3 eras according to changes in donor allocation criteria (Era 1: January 2010/May 2014; Era 2: June 2014/May 2017; Era 3: June 2017/December 2020). Over time, the proportion of candidates listed with intra-aortic balloon pumps decreased (Era 1=55.9%, Era 2=32%, Era 3=0.9%; p < 0.001), while the proportion of candidates listed with surgical continuous-flow temporary VADs (Era 1=10.6%, Era 2=32%, Era 3=49.1%; p < 0.001) and percutaneous VADs (Era 1=0.3%, Era 2=6.3%; Era 3=17.2%; p < 0.001) increased. Rates of HTx increased from Era 1 (79.4%) to Era 2 (87.8%), and Era 3 (87%) (p=0.004), while rates of death before HTx decreased (Era 1=17.7%; Era 2=11%, Era 3=12.4%; p=0.037) Median time from listing to HTx increased in patients supported with intra-aortic balloon pumps (Era 1=8 days, Era 2=15 days; p < 0.001) but remained stable in other candidates (Era 1=6 days; Era 2=5 days; Era 3=6 days; p=0.134). One-year post-transplant survival was 71.4% in Era 1, 79.3% in Era 2, and 76.5% in Era 3 (p=0.112). Preoperative bridging with ECMO was associated with increased 1-year post-transplant mortality (adjusted HR=1.71; 95% CI 1.15-2.53; p=0.008). During the period 2010 to 2020, successive changes in the Spanish organ allocation protocol were followed by a significant increase of the rate of HTx and a significant reduction of waiting list mortality in candidates supported with temporary MCS. One-year post-transplant survival rates remained acceptable.

Current state of antimicrobial stewardship and organ transplantation in Spain.

Solid-organ transplantation (SOT) remains the best therapeutic option for end-stage organ disease. Regrettably, SOT recipients are disproportionately affected by nosocomial infections produced by multidrug-resistant (MDR) microorganisms and antimicrobial adverse events. Both have a negative impact on the patient´s outcome. Description of data concerning the antimicrobial stewardship program (ASP) in SOT recipients of the University Hospital "12 de Octubre", and review of other Spanish ASPs. From May 2017 to December 2021, the ASP issued 2.785 recommendations. Approximately, 4.9% were aimed at improving the antimicrobial treatment administered to SOT recipients. Treatment discontinuation or change to a better therapeutic regimen was recommended in 51.8% and 26.3% of cases, respectively. The acceptance rate of the recommendations was close to 92%. Between June 2015 and March 2016, a quasi-experimental study consisting of a joint ASP and hospital-acquired infection control (HAIC) initiative, which included kidney transplant recipients, reported a significant reduction in the consumption of meropenem, vancomycin and ciprofloxacin, and a reduction in the incidence of global bacterial infections, upper urinary tract infections, and cystitis. Although Spain has several robust regional ASPs (e.g., VINCat and PIRASOA), data specifically concerning SOT patients is lacking. ASP coupled with HAIC programs have proven to be effective in SOT, and should be implemented in centers that perform transplantation. Since data is scarce, Spanish centers which have ASP should report their experience in SOT. Understanding the efficacy and safety of the Spanish ASP´s intervention in the SOT population is essential and deserves further study.

MO991: Covid-19 Infection After Kidney Transplantation in Spain: Comparable Impact Throughout Six Epidemic Waves

BACKGROUND AND AIMSThe successive COVID-19 epidemic waves have significantly influenced kidney transplantation (KT) programs. Contact protection together with vaccination are the principal protective tools for KT recipients. We reviewed the impact of COVID-19 infection in KT recipients throughout the different epidemic waves.METHODOf 900 active KT recipients in our program, 160 (17.8%) have suffered COVID-19 infection during the six epidemic waves: first (March–August 2020), second (September–December2020), third (January–March 2021), fourth (April–May 2021), fifth (June–September 2021) and sixth (October–December 2021, preliminary data). We compared the clinical evolution and the impact of vaccination.RESULTSInfected KT recipients were younger in the third and fourth waves (P < 0.001). We observed a higher percentage of pneumonia and hospital admission in the first and fifth waves (P = 0.045, P = 0.016) (Table 1), without differences in ICU admission, and with the disappearance of asymptomatic cases after the third wave. The highest mortality was observed in KT recipients >65 years old infected within the first 6 months after KT (P = 0.006) and overall mortality was higher in the first wave (P = 0.033). Mortality in hospitalized KT recipients and those admitted in the ICU were similar along the 5 waves, without clear impact of vaccination (P = 0.251). On the 5 January 2022, we have already accumulated an incidence of COVID in KT of 3.1% (sixth wave, 77% with booster vaccination), similar to the first wave (3.8%), with 12.5% mortality, similar to second, third and fifth waves, in patients with outcome (53.3%).CONCLUSIONThe incidence of COVID-19 in KT recipients has been high in all the waves of the pandemic in Spain. Global mortality has diminished after the first wave, and the time until outcome has increased. The highest mortality occurs in the subgroup of old KT recipients early after KT. Vaccination has not significantly reduced the mortality in KT with Covid who require hospital or ICU admission.

POSB119 Economic Impact of Once-Daily MeltDose Extended-Release Tacrolimus (LCP-TAC) in Patients with Kidney or Liver Transplantation in Spain

Tacrolimus is an immunosuppression drug widely used for prevention of allograft rejection in kidney and liver transplantations. The once-daily extended-release tacrolimus (LCP-Tac) is a novel formulation for tacrolimus, differentiated by using the MeltDose technology which was designed to enhance the bioavailability of drugs with low water solubility. This study assessed the economic impact of the use LCP-Tac compared with other once-daily extended-release tacrolimus (PR-Tac) and with twice-daily immediate-release tacrolimus (IR-Tac) in patients with kidney or liver transplantation.

Expanding Indications of Liver Transplantation in Spain: Consensus Statement and Recommendations by the Spanish Society of Liver Transplantation.

The number of patients awaiting liver transplantation (LT) in Spain has halved from 2015 to 2019 due to the reduction of candidates with hepatitis C and the successful implementation of nonheart beating donation programs across the country. The Spanish Society for Liver Transplantation has committed to take advantage of this situation by developing consensus around potential areas to expand the current indications for LT. The consensus group was composed of 6 coordinators and 23 expert delegates, each one representing an LT institution in Spain. A modified Delphi approach was used to identify areas to expand indications for LT and to build consensus around paramount aspects, such as inclusion criteria and waitlist prioritization within each area. The scientific evidence and strength of recommendations were assessed by the "Grading of Recommendations Assessment, Development, and Evaluation" system. The consensus process resulted in the identification of 7 potential areas to expand criteria in LT: recipient's age, hepatocellular carcinoma, alcoholic hepatitis, acute-on-chronic liver failure, hilar and intrahepatic cholangiocarcinoma, and unresectable liver metastases of colorectal cancer. We present the main recommendations issued for each topic, together with their core supporting evidence. These recommendations may allow for expanding criteria for LT homogenously in Spain and may provide a guidance to other countries/institutions facing a similar scenario.

Cost-effectiveness analysis of defibrotide in the treatment of patients with severe veno-occlusive disease/sinusoidal obstructive syndrome with multiorgan dysfunction following hematopoietic cell transplantation in Spain

Aims This study evaluated cost-effectiveness of defibrotide vs best supportive care (BSC) for the treatment of hepatic veno-occlusive disease/sinusoidal obstructive syndrome (VOD/SOS) with multiorgan dysfunction (MOD) post-hematopoietic cell transplantation (HCT) in Spain. Materials and methods A two-phase Markov model, comprising a 1-year acute phase with daily cycles and a lifetime long-term phase with annual cycles, was adapted to the Spanish setting. The model included a cohort of patients with severe VOD/SOS (defined as VOD/SOS with MOD) post-HCT. For the acute phase, efficacy and VOD/SOS-related length of stay were obtained from a phase 3 defibrotide study (NCT00358501). VOD/SOS-related hospital stays were 7.5 and 23.2 days in defibrotide-treated and BSC patients, respectively. Defibrotide-treated patients spent 30% of their stay in the intensive care unit vs 60% in BSC patients. Assumptions for the long-term phase and utility values were obtained from the literature. Costs were from the Spanish Health System perspective (€2019). Defibrotide cost was based on 25 mg/kg/day over 17.5 days, using local expert opinion. Life-years (LYs), quality-adjusted LYs (QALYs), and costs were estimated over a lifetime horizon, applying a 3% discount rate for costs and outcomes. Sensitivity analyses assessed the robustness of the results. Results Defibrotide produced an additional 1.214 QALYs and 1.348 LYs vs BSC, with a total cost of €33,708 more than BSC alone. However, defibrotide resulted in savings up to €16,644/patient for cost of hospital stay. Difference between costs and effective measures led to ratios of €27,757/QALY and €25,007/LY gained. Additional hospital stays had the greatest influence on base-case results. Probabilistic analysis confirmed the robustness of the deterministic results. Limitations Limitations include use of historical controls and assumptions extrapolated from the literature. Conclusions This cost-effectiveness model, adapted to the Spanish setting, showed that defibrotide is a cost-effective alternative to BSC alone in patients with severe VOD/SOS post-HCT.

Actual Profile of the Patient Seeking for Hair Transplantation in Spain: The Most Frequent Aesthetic Surgical Procedure in Male

Hair transplantation is the most frequently practiced aesthetic surgery procedure in males all over the World. The first western country in number of transplants is USA followed by Japan (first eastern country), Italy (first European country) and then, Argentina and Brazil in South America. In Spain (first European country in number of aesthetic surgeries) no other procedure increased so exponentially (200%) its popularity in such a short time (3 years).

Perfil sociodemográfico e clínico de transplantados de medula óssea: Centros de referências no Brasil e Espanha

Caracterizar o perfil sociodemográfico e clínico de Transplantados de Medula Óssea de dois centros no Brasil e um da Espanha. Estudo transversal, realizado com 40 respondentes adequados aos critérios de inclusão. Os dados foram coletados de março de 2016 a outubro de 2017. Constatou-se uma diferenciação de gênero e faixa etária entre os países: predomínio do gênero feminino (25%); faixa etária de 21 a 50 anos (30%) no Brasil e do gênero masculino (37,5%); faixa etária de 51 a 70 anos (35%), na Espanha. Houve similaridade, respectivamente, de raça/cor branca, escolaridade 1º grau, estado civil casado, religião católica, renda de 1 a 2 salários mínimos, doença primária Leucemias e. maior frequência de transplante Halogênico na Espanha (37,5%). O estudo teve um avanço fortalecedor das ações de enfermagem, instrumentalizando-as quanto a organização, planejamento e tomada de decisões e na promoção do cuidado junto aos pacientes e familiares.

Predisposition Toward Living Liver Donation Is Low Among Relatives of Patients on the Waiting List for Transplantation in Spain

IntroductionThe attitude toward living liver donation (LLD) among the Spanish population is mostly positive; however, the reality is that liver transplants from live donations are currently minimal. Given this situation, studies that analyze these discrepancies should be carried out. ObjectiveAnalyze the attitude toward LLD among family members of patients on the waiting list for liver transplantation. MethodPopulation under study. First-degree relatives of the patients included in the waiting list for liver transplantation. Inclusion criteria. 1. Have the patient's authorization for family members to participate; 2. Accept, the relative, to participate in this investigation; and 3. Be over 18 years old. Opinion survey. The attitude toward LLD is assessed through a questionnaire on psychosocial aspects. ResultsPatients who accepted family members’ participation in the study were 21 of 112, of which 9 placed restrictions on family access, and 12 authorized family members without restrictions. The participants were 1. children: 52.2% (n = 24); 2. brothers: 30.5% (n = 14); and 3. partners: 17.3% (n = 14). Finally, the authorized relatives and participants in the study were 45. Of these, only 44% (n = 20) would accept to be donors. ConclusionsThe access to the LLD of the relatives starts from the restriction and initial rejection of the patients themselves on the waiting list. The promotion of LDD is to initially sensitize patients.

The odd situation of pancreas transplantation in Spain

The odd situation of pancreas transplantation in Spain

HTLV-1 infection in solid organ transplant donors and recipients in Spain

BackgroundHTLV-1 infection is a neglected disease, despite infecting 10–15 million people worldwide and severe illnesses develop in 10% of carriers lifelong. Acknowledging a greater risk for developing HTLV-1 associated illnesses due to immunosuppression, screening is being widely considered in the transplantation setting. Herein, we report the experience with universal HTLV testing of donors and recipients of solid organ transplants in a survey conducted in Spain.MethodsAll hospitals belonging to the Spanish HTLV network were invited to participate in the study. Briefly, HTLV antibody screening was performed retrospectively in all specimens collected from solid organ donors and recipients attended since the year 2008.ResultsA total of 5751 individuals were tested for HTLV antibodies at 8 sites. Donors represented 2312 (42.2%), of whom 17 (0.3%) were living kidney donors. The remaining 3439 (59.8%) were recipients. Spaniards represented nearly 80%.Overall, 9 individuals (0.16%) were initially reactive for HTLV antibodies. Six were donors and 3 were recipients. Using confirmatory tests, HTLV-1 could be confirmed in only two donors, one Spaniard and another from Colombia. Both kidneys of the Spaniard were inadvertently transplanted. Subacute myelopathy developed within 1 year in one recipient. The second recipient seroconverted for HTLV-1 but the kidney had to be removed soon due to rejection. Immunosuppression was stopped and 3 years later the patient remains in dialysis but otherwise asymptomatic.ConclusionThe rate of HTLV-1 is low but not negligible in donors/recipients of solid organ transplants in Spain. Universal HTLV screening should be recommended in all donor and recipients of solid organ transplantation in Spain. Evidence is overwhelming for very high virus transmission and increased risk along with the rapid development of subacute myelopathy.

La extraña situación del trasplante de páncreas en España

La extraña situación del trasplante de páncreas en España

Spanish Heart Transplant Registry. 29th Official Report of the Spanish Society of Cardiology Working Group on Heart Failure

Introduction and objectivesThe present report updates the characteristics and results of heart transplantation in Spain, mainly focused in the 2008-2017 period. MethodsWe describe the recipient and donor characteristics, surgical procedures, and outcomes of heart transplants performed in 2017. The 2017 data were compared with those obtained from 2008 to 2016. ResultsA total of 304 cardiac transplants were performed in 2017. Between 1984 and 2017, 8173 procedures were performed, 2689 of them after 2008. Significant temporal trends were observed in recipient characteristics (lower pulmonary vascular resistance, lower use of mechanical ventilation, and a higher percentage of diabetic patients and those with previous cardiac surgery), donor characteristics (older donor age and a higher percentage of female donors and those with a prior cardiac arrest) and procedures (lower ischemia time). In 2017, 27% of patients were transplanted after undergoing mechanical ventricular assistance (P <.001 for trend). In the last decade, there was a trend to better survival. ConclusionsAround 300 transplants per year were performed in Spain in the last decade. There was a significant increase in the use of pretransplant mechanical circulatory support and a trend to improved survival.

Registro Español de Trasplante Cardiaco. XXIX Informe Oficial de la Sección de Insuficiencia Cardiaca de la Sociedad Española de Cardiología (1984-2017)

Introducción y objetivosThe present report updates the characteristics and results of heart transplantation in Spain, mainly focused in the 2008-2017 period. MethodsWe describe the recipient and donor characteristics, surgical procedures, and outcomes of heart transplants performed in 2017. The 2017 data were compared with those obtained from 2008 to 2016. ResultsA total of 304 cardiac transplants were performed in 2017. Between 1984 and 2017, 8173 procedures were performed, 2689 of them after 2008. Significant temporal trends were observed in recipient characteristics (lower pulmonary vascular resistance, lower use of mechanical ventilation, and a higher percentage of diabetic patients and those with previous cardiac surgery), donor characteristics (older donor age and a higher percentage of female donors and those with a prior cardiac arrest) and procedures (lower ischemia time). In 2017, 27% of patients were transplanted after undergoing mechanical ventricular assistance (P <.001 for trend). In the last decade, there was a trend to better survival. ConclusionsAround 300 transplants per year were performed in Spain in the last decade. There was a significant increase in the use of pretransplant mechanical circulatory support and a trend to improved survival.